European Health Data Space Regulation
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Table of Contents
Chapter I – General provisions
Chapter II – Primary use
Chapter III – Ehr systems and wellness applications
Chapter IV – Secondary use
Chapter V – Additional actions
Chapter VI – European governance and coordination
Chapter VII – Delegation of powers and committee procedure
Chapter VIII – Miscellaneous
Chapter IX – Deferred application, transitional and final provisions
Recitals (115)
Annexes
Recital 55
(55) In the context of the EHDS, electronic health data already exist and are being collected by, among others, healthcare providers, professional associations, public institutions, regulators, researchers and insurers in the course of their activities. Those data should also be made available for secondary use, that is to say for processing of data for purposes other than those for which they were collected or produced, however, many of such data are not made available for processing for such purposes. This limits the ability of researchers, innovators, policy-makers, regulators and doctors to use those data for different purposes, including research, innovation, policymaking, regulatory purposes, patient safety or personalised medicine. In order to fully exploit the benefits of secondary use, all health data holders should contribute to this effort in making different categories of electronic health data they are holding available for secondary use, provided that such effort is always made through effective and secured processes, with due respect for professional duties, such as confidentiality duties.